Anti-Obesity Treatments 2007 to 2012 A blockbuster target market

1 Executive Summary: Anti-Obesity Treatments 2007-2012

2 An Introduction to Obesity and Its Treatment
2.1 What is Obesity?
2.1.1 How Serious is the Problem?
2.1.2 Fat is Necessary to Store Energy in the Body
2.1.3 Drugs Have a Role in Treating Obesity
2.1.4 Obesity is a Chronic Disease
2.1.5 Obesity Greatly Increases Risk Factors for a Range of Other Diseases
2.1.6 Obesity is Very Prevalent Worldwide
2.1.7 Body Weight is Dependent Upon Several Factors
2.2 How is Obesity Measured?
2.2.1 Weight-for-Height Tables
2.2.2 Body Mass Index
2.2.3 Waist Circumference
2.3 Urbanisation, Modernisation and Economic Development Have Contributed to Obesity
2.3.1 Urban Areas Show Higher Levels of Obesity
2.3.2 Technological Developments Have Contributed to the Problem of Obesity
2.3.3 Modernisation Has Effected Obesity Levels in Native Populations
2.4 Those Most At Risk Are Poor in Developed Countries and Wealthy in Developing Nations
2.4.1 Importing Poor Eating Habits
2.4.2 The Costs of Poor Diets to Individuals and Society
2.5 Obesity Overtakes Smoking for Medical Costs in the US
2.6 Obesity in the US
2.6.1 Prevalence of Obesity Has Increased Steadily in Recent Years
2.6.2 There is a High Prevalence of Obesity Among Children in the US
2.7 Obesity in the UK
2.7.1 High Incidence and Social Costs
2.7.2 Increasing Juvenile Obesity
2.7.3 National and Local Efforts Required
2.8 Effects of Obesity on Health: Linked Conditions Have High Social and Economic Cost
2.9 Childhood Obesity
2.10 Factors Causing Obesity
2.10.1 Genetics
2.10.2 Specific Genetic Factors
2.10.3 Environment
2.10.4 Diet
2.10.5 Behaviour
2.10.6 Regular Physical Exercise
2.11 Treatment of Obesity
2.12 Treatment of Obesity With Drugs
2.12.1 Drugs May be Used Under Strict Clinical Guidance
2.12.2 Types of Drugs for Treating Obesity
2.13 Lipase inhibitors
2.13.1 Orlistat the First of the Lipase Inhibitors Currently Leads the Anti-Obesity Market
2.14 Anorectic Drugs
2.14.1 Sibutramine Has Achieved Modest Success
2.14.2 Phentermine Hydrochloride – An Older Drug
2.14.3 Rimonabant – a Promising Cannabinoid Receptor Blocker
2.15 There is Much Scope for Future Development of Treatments for Obesity

3 The World Market for Anti-Obesity Drugs, 2006-2012
3.1 The Anti Obesity Market Generated Sales in Excess of $1bn in 2006
3.1.1 Xenical and Meridia Overcame Difficulties in the Anti-Obesity Market in the Late 1990s
3.1.2 New Drugs Such as Acomplia Have High Expectations to Live Up To
3.1.3 Reductil/Ectiva/Meridia and Xenical Have More Limited Scope for Expanded Indications than Acomplia
3.2 Xenical and Reductil/Ectiva/Meridia are More Limited in their Scope for Gaining Further Indications than Acomplia
3.3 The Anti-Obesity Market Has Proved Very Difficult to Crack So Far
3.3.1 Only Two Drugs are Currently Approved for Long-Term Treatment of Obesity
3.3.2 Visiongain Believes That Significant Advances Will Occur in this Market With Potentially High Revenues for Next-Generation Products
3.4 Roche Currently Leads the Global Prescription Anti-Obesity Market
3.5 The Global Anti-Obesity Market Will Expand Strongly from 2006 to 2012
3.5.1 Xenical and Reductil will be Overtaken by Acomplia
3.5.2 Life-Long Therapy with Drugs May Constitute the Future of Obesity Management
3.6 Xenical Will Continue to Show Growth to 2009 Then Decline Gradually
3.6.1 Xenical Versus Meridia – Efficacy and Side Effects
3.6.2 Completion of Key Studies on Orlistat in 2002
3.6.3 Indication for Use in Adolescents in both US and EU – a Significant Advantage for Xenical
3.6.4 US Label Change to Include Delay of Diabetes Type 2 Onset Information
3.6.5 Lifecycle Management Potential Includes Possible Anti-Cancer Role for Xenical
3.6.6 OTC Version of Orlistat Approved in the US – Licensing Deal With GSK
3.6.7 Discontinuation of Development of Orlistat by Chugai in Japan
3.7 Reductil/Ectiva/Meridia Will Also Lose Out to Acomplia from 2006-2012
3.7.1 Sibutramine is a Dual Serotonin (5HT)/Noradrenaline Re-uptake Inhibitor Launched in the US in 1998
3.7.2 Problems for Reductil/Meridia
3.7.3 Abbott has Entered into Various Licensing Deals for Sibutramine
3.8 Sales of Clobenzorex Will Continue to Expand Throughout the Forecast Period
3.9 Acomplia Will Be the First Blockbuster in the Anti-Obesity Market Segment Comment
3.9.1 Acomplia Launched in Europe in Mid 2006 with US Approval Pending
3.9.2 Acomplia Has Therapeutic Promise that Should Ensure High Sales
3.9.3 Acomplia Was Rejected by FDA Panel in June 2007 – Sanofi-Aventis Responded by Withdrawing its Application Temporarily
3.9.4 Success of Acomplia Will be Driven by Expansion of Indications
3.9.5 Phase III Results for Acomplia were Promising
3.9.6 Further Trials are in Progress for Acomplia
3.9.7 The RIO Studies on Diabetes and Lipids Were Promising for Acomplia
3.9.8 The SERENADE Trial Reinforced Earlier Studies – Amelioration of Other Aspects of Metabolic Syndrome
3.9.9 In Wake of FDA Panel Rejecting Acomplia, Sanofi-Aventis Announced Plans to Submit Additional Safety Data to European Authorities 3.9.10 Reimbursement for Acomplia is a Serious Concern for Sanofi-Aventis
3.9.11 Rights for Japan Reverting to Sanofi-Aventis 3.10 Sales of Phentermine Will Continue to Decline Slowly from 2006-2012
3.10.1 Phentermine is a Sympathomimetic Appetite Suppressant
3.10.2 Phentermine is a Long-Established Treatment that Still Achieves High Prescription Volumes – Generics Make it a Lower Cost Therapy
3.10.3 Phentermine Is Subject to the Controlled Substances Act in the US
3.11 Other Anti-Obesity Drugs Will Seize an Increasingly Significant Proportion of Total Sales in the Sector
3.11.1 There are Promising Developments Currently in Mid to Late Stage Clinical Testing
3.11.2 Compounds For Developed for Type 2 Diabetes Have Potential in Treating Obesity As Well
3.12 While the Past Has Been Difficult for Anti-Obesity Treatments, There is Optimism for the Future
3.13 The Anti-Obesity Market is Fragmented but Future Growth Is Assured by Rising Awareness of Obesity as a Major Health Problem in the Developed and Developing World
3.14 Safety Issues Affect Leading Anti-Obesity Drugs
3.15 The Anti-Obesity Market Will Expand Rapidly as Prescribers and Healthcare Providers Recognise the Pressing Need to Avert This Most Serious Threat to Health

4 Forces Affecting the Anti-Obesity Market
4.1 SWOT Analysis of the Anti-Obesity Market
4.2 An Expanding Patient Population Constitutes the Principal Driver in the Anti-Obesity Market
4.3 The Principal Restraints in the Anti-Obesity Market
4.4 Major Success in the Anti-Obesity Drugs Market Has Proved to Be Elusive to Date
4.4.1 Many Doctors and Healthcare Bodies Believe that Drugs Play an Important Role in Treating Obesity
4.5 Safety Concerns Over Anti-Obesity Treatments
4.5.1 Market for Anti-Obesity Drugs Has Encountered Mixed Fortunes in Recent Years
4.5.2 Two Drugs Approved for Long-Term Treatment of Obesity
4.5.3 The Anti-Obesity Market Suffered After the Withdrawal of Fenfluramine and Dexfenfluramine
4.5.4 Public Citizen Filed a Petition With The FDA Claiming that Xenical Should be Withdrawn
4.5.5 Obstacles facing US Approval for Rimonabant Casts Shadow Over Other Obesity Drugs
4.6 The World Health Organisation Considers Obesity to be an Epidemic
4.7 Convincing Stakeholders of the Efficacy and Safety of Anti-Obesity Drugs Remains a Great Challenge for the Industry
4.7.1 There is a Persisting Belief That Drugs Have a Limited Role in Treating Obesity
4.7.2 Lack of Adequate Reimbursement Limits Potential of Anti-Obesity Drugs
4.8 US Health Gains Weakened by High Incidence of Excessive Weight and Obesity
4.8.1 Overweight and Obesity Are Among The Most Pressing New Health Challenges
4.8.2 Risks Caused by Obesity Compared with Those of Tobacco Use
4.8.3 Over Half of US Residents are Overweight
4.8.4 Community-Based Recommendations for Tacking Obesity in the US
4.9 EU Health Commissioner Reports That More Than Half Of Adults in the EU are Currently Overweight 4.10 Non Medicinal Treatments that Accompany Drug-Based Therapy – When Successful These Approaches Lessen the Requirement for Pharmaceuticals
4.10.1 Reducing Energy Intake Through Changes to Diet and Eating Patterns
4.10.2 Increasing Physical Activity
4.10.3 Behavioural Therapy
4.11 Weight Loss Surgery For Severe Obesity – A Last Resort When Drug-Based Treatments Fail
4.12 Potential Risks of Anti-Obesity Medication Other Than Side-Effects
4.12.1 Potential for Abuse or Dependence
4.12.2 Development of Tolerance
4.12.3 Reluctance to View Obesity as a Chronic Disease
4.13 Over-the-Counter Drugs and Herbal Remedies
4.13.1 OTC Version of Orlistat Approved in Early 2007
4.14 Obesity Will Constitute a Devastating Burden on Healthcare and on Society in General Unless it is Effectively Prevented and Treated
4.15 Critics Warn of Over-Reliance on Anti-Obesity Drugs
4.15.1 Use of Obesity Drug Increases in Britain
4.15.2 Critics Accuse Doctors of Overlooking Side Effects of Drugs and Healthcare Authorities of Not Doing Enough to Encourage Lifestyle Changes
4.15.3 Claims for Anti-Obesity Drug Disputed
4.16 Surgery And Drugs for Children To Tackle Obesity “Epidemic” in UK
4.17 There is Good Scope for New Drugs to Treat Obesity, Leading UK Expert Acknowledges
4.18 Controversy Over Vested Interests and Misinformation in Obesity

5 Obesity in the Leading Pharmaceutical Markets
5.1 The US Will Still Have The Highest Prevalence of Obesity in 2012
5.1.1 WHO Considers Obesity to be a Global Epidemic
5.1.2 Both Germany and the UK Will Have High Prevalence of Obesity
5.1.3 Lifestyle Issues Raising the Obesity Levels
5.2 Sales of Anti-Obesity Drugs Will Rise Steadily in the US from 2006 to 2012
5.2.1 The UK Will Have The Second-Highest Sales of Anti-Obesity Drugs
5.2.2 Although Japan Will Retain a Low Prevalence of Obesity, the Relative Increase in Numbers of Obese People Will Be High
5.3 High Cost of Obesity in the UK Will Drive Sales of Anti-Obesity Medication
5.4 Health Survey for England Shows Marked Increase in Childhood Obesity
5.5 Drive to Reduce UK’s High Obesity Levels Given Boost by Online Resource
5.6 The National Institutes of Health Recognise that Obesity Now Constitutes an Epidemic in the US
5.6.1 The NIH Obesity Research Task Force
5.6.2 Efforts in the US and Europe Will Benefit the Development of New Pharmaceutical Treatments for Obesity

6 Experts’ Views on Main Issues in the Treatment of Obesity
6.1 The Most Important Unmet Medical Needs in The Treatment of Obesity
6.2 The Most Favoured Type of Anti-Obesity Treatment by the Start of Next Decade
6.3 Future Prospects for Efficacy and Safety
6.4 Funding of Anti-Obesity Treatments
6.5 The Anti-Obesity Market in Developing Nations
6.6 Concluding Thoughts

7 Pipeline Developments in Anti-Obesity Treatments
7.1 Agents in Phase 2 of Clinical Development for Obesity
7.1.1 Novo Nordisk’s Liraglutide
7.1.2 Sanofi-Aventis’ Surinabant (SR 147778)
7.1.3 Pfizer’s CP 741952 and CP 866087
7.1.4 Alizyme’s Cetilistat (ATL 962)
7.1.5 Solvay’s SLV 319 (BMS 646256)
7.1.6 Amylin’s Pramlintide (Symlin, Normylin)
7.1.7 Kissei’s 869682
7.1.8 Metabolic’s AOD 9604
7.1.9 Sanofi-Aventis’ AVE 1625
7.1.10 Orexigen’s Bupropion/Zonisamide (Empatic/Excalia)
7.1.11 Genzyme’s GT 389255
7.1.12 Amgen’s Metreleptin
7.1.13 VIVUS’ Phentermine/topiramate (MK 0493)
7.1.14 7TM Pharma’s TM 30338
7.1.15 Shionogi’s S 2367
7.1.16 Obecure
7.2 Agents in Phase 3 of Clinical Development for Obesity
7.2.1 Merck & Co’s Taranabant
7.2.2 Pfizer’s CP 945598
7.2.3 Orexigen’s Bupropion and Naltrexone (Contrave)
7.2.4 Arena’s Lorcaserin
7.3 Discussion of Current Pipeline Developments

8 Conclusions
8.1 Obesity is a Serious Condition With High Prevalence
8.2 Drugs Have a Role in Treating Obesity
8.3 The Anti-Obesity Market Has Proved Very Difficult to Crack So Far
8.4 The Global Anti-Obesity Market Will Expand Strongly from 2006 to 2012
8.4.1 Xenical and Reductil will be Overtaken by Acomplia
8.5 An Expanding Patient Population Constitutes the Principal Driver in the Anti-Obesity Market
8.6 The Principal Restraints in the Anti-Obesity Market
8.7 Geographical Breakdown of Revenues in the Anti-Obesity Market
8.7.1 The US Will Still Have The Highest Prevalence of Obesity in 2012
8.7.2 Both Germany and the UK Will Have High Prevalence of Obesity
8.7.3 Sales of Anti-Obesity Drugs Will Rise Steadily in the US from 2006 to 2012
8.7.4 The UK Will Have The Second-Highest Sales of Anti-Obesity Drugs
8.8 There are Promising Developments Currently in Mid to Late Stage Clinical Testing
8.9 Outlook for the Future

Appendices
Appendix 1: Conditions Associated with Obesity Appendix 2: About visiongain Appendix 3: Visiongain Report Evaluation Form

List of Tables
Table 2.1 BMI Classification Bands
Table 2.2 Prevalence of Obesity (%) Amongst US Adults by Characteristics, 1991-2001
Table 3.1 Leading Anti-Obesity Prescription Drugs ($m), 2006
Table 3.2 Leading Companies for Anti-Obesity Prescription Drugs, 2006
Table 3.3 Sales of Anti-Obesity Prescription Drugs ($m), 2006-2012
Table 3.4 CAGR Values (%) for Leading Anti-Obesity Prescription Drugs, 2006-2012
Table 3.5 Market Shares (%) for Leading Anti-Obesity Prescription Drugs, 2006 & 2012
Table 3.6, US Patents on Orlistat
Table 3.7 US Patents on Sibutramine
Table 3.8 US Patents on Rimonabant
Table 4.1 Table A SWOT Chart for Anti-Obesity Treatments, 2007-2012
Table 5.1 Prevalence of Obesity in the Leading Pharmaceutical Markets, 2006 and 2012
Table 5.2 Share (%) of the Obesity Market and Sales ($m) in the Leading Pharmaceutical Markets, 2006 and 2012

List of Figures
Figure 2.1 Prevalence of Obesity in US Total and by Gender, 1991-2004
Figure 2.2 Prevalence of Obesity in US by Age Group, 1991-2004
Figure 3.1 Leading Anti-Obesity Prescription Drugs ($m), 2006
Figure 3.2 Leading Anti-Obesity Prescription Drugs, Market Share (%), 2006
Figure 3.3 Leading Anti-Obesity Prescription Drugs, Sales Growth (%), 2012
Figure 3.4 Leading Companies for Anti-Obesity Prescription Drugs, 2006
Figure 3.5 Leading Companies for Anti-Obesity Prescription Drugs, Market Share (%), 2006
Figure 3.6 Sales of Leading Anti-Obesity Prescription Drugs ($m), 2006-2012
Figure 3.7 Total Sales ($m) of Anti-Obesity Prescription Drugs, 2006-2012
Figure 3.8 Market Shares (%) for Leading Anti-Obesity Prescription Drugs, 2006
Figure 3.9 Market Shares (%) for Leading Anti-Obesity Prescription Drugs, 2006 & 2012
Figure 3.10 Sales ($m) of Xenical, 2006-2012
Figure 3.11 Sales ($m) of Reductil/Meridia, 2006-2012
Figure 3.12 Sales ($m) of Clobenzorex, 2006-2012
Figure 3.13 Sales ($m) of Acomplia, 2006-2012
Figure 3.14 Sales ($m) of Phentermine, 2006-2012
Figure 3.15 Sales ($m) of Other Anti-Obesity Drugs, 2006-2012
Figure 5.1 Prevalence (%) of Obesity in the Leading Pharmaceutical Markets, 2006 and 2012
Figure 5.2 Prevalence (Millions) of Obesity in the Leading Pharmaceutical Markets, 2006 and 2012
Figure 5.3 Increase in Numbers (%) of Obesity Sufferers in the Leading Pharmaceutical Markets, 2006 and 2012
Figure 5.4 Share (%) of the Obesity Market in the Leading Pharmaceutical Markets, 2006 and 2012
Figure 5.5 Sales ($m) in the Leading Pharmaceutical Markets, 2006 and 2012
Figure 5.6 Growth Rates (CAGR %) for The Anti-Obesity Segments of The Leading Pharmaceutical Markets
Figure 8.1 Total Sales ($m) of Anti-Obesity Prescription Drugs, 2006-2012
Figure 8.2 Sales of Leading Anti-Obesity Prescription Drugs ($m), 2006-2012